MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAESTRO FOOT SWITCH; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	86250
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the foot switch would not stop ablation.During an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure, the physician was doing an ablation using the maestro 4000 footswitch, when the physician's foot was lifted to come off ablation, it the maestro 4000 continued to ablate.Ablation was stopped by switching it off on the machine.There were not patient complications reported.
Additional Manufacturer Narrative
Date of event corrected from (b)(6) 2018 to (b)(6) 2019.The device was returned for analysis.The foot guard was in overall good physical condition.Strain relief at the foot pedal was in good physical shape.There was not damage to the cord's insulation jacket.The pedal pressed down evenly with a normal clicking sound.The connector to the maestro was in good physical shape, and the pins were straight and the grounding shield was intact.Using an ohm meter, the foot switch was placed on he floor and activated.The switch turned on and off with no issues.The cord was pulled and flexed along the length and near the connector and pedal's strain reliefs.No issues were observed.There were no electrical or mechanical failures found with the foot switch.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that the foot switch would not stop ablation.During an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure, the physician was doing an ablation using the maestro 4000 footswitch, when the physician's foot was lifted to come off ablation, it the maestro 4000 continued to ablate.Ablation was stopped by switching it off on the machine.There were not patient complications reported.

• Brand Name: MAESTRO FOOT SWITCH
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9309532
• Report Number: 2134265-2019-13708
• Device Sequence Number: 16677107
• Product Code: OAD
• UDI-Device Identifier: 08714729862437
• UDI-Public: 08714729862437
• Combination Product (Y/N): N
• Initial Reporter Country: WA
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 86250
• Device Catalogue Number: 86250
• Device Lot Number: 0326797022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 01/28/2020
• Patient Sequence Number: 1